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NMPF Challenges FDA’s Hazard Analysis Guidance

March 9, 2017

In late February, NMPF challenged a number of flaws in FDA’s Hazard Analysis and Risk-Based Preventive Control for Human Food Draft Guidance for Industry, also known as the Preventive Control for Human Food rule, under the Food Safety Modernization Act (FSMA).

In the guidance, the U.S. Food and Drug Administration (FDA) identified hazards that the dairy industry should consider when developing food safety plans, as required by the rule. NMPF replied that FDA’s definition of a “hazard” includes consideration of the severity of a potential injury or illness, as well as the probability that one will occur. FDA listed many hazards that NMPF argued would not result in an injury or illness or had little to no probability of occurring.

FDA identified drug residues in dairy products as a chemical hazard that should be considered when conducting a hazard analysis. NMPF challenged this concern, pointing out that the dairy industry tests approximately 99 percent of the raw milk supply for beta-lactam residues. Last year’s national survey of milk tankers found that only 0.011 percent tested positive, while the testing of retail-ready dairy products found zero residues. In addition, a review of the scientific literature failed to identify any allergic reaction to drug residues in milk. FDA also identified lactose as a potential hazard, and suggested allergen labeling as a form of preventive control. However, lactose is not an allergen and therefore would not trigger an allergic reaction. NMPF asked for that section of the guidance to be redrafted to avoid confusing consumers about the distinction between milk protein allergies and lactose intolerance.

However, NMPF did concur with FDA that pathogens in raw milk are a hazard that should be addressed, which is why milk and dairy products are pasteurized and raw milk sales should be restricted.

In a second set of comments on the guidance, NMPF pointed out that the product categories were inappropriately named. NMPF argued that for the sake of consistency, clarity, and to avoid consumer confusion, the names of non-dairy alternatives should reflect federal standards of identity. NMPF requested the names for some products to be changed to rice or soy “beverage” and “soy-based frozen dessert,” or else include the word “imitation.” NMPF will continue to argue for proper use of standardized dairy terms.